Nizoral tablets contain the active ingredient ketoconazole, which is a type of medicine called an antifungal. It is used to treat infections with fungi and yeasts.

What is it used for?

Nizoral tablets are licensed to treat fungal infections of the skin, hair or mucous membranes (eg moist linings of the mouth, nose or vagina) that can't be treated with topical ketoconazole due to the site or extent of the infection, and cannot be treated with other antifungals. These infections include the following:

However, following a review of this medicine by the European Medicines Agency, doctors and pharmacists were advised in July 2013 that ketoconazole tablets should no longer be used to treat fungal infections. This is because the medicine carries a risk of causing side effects on the liver that is now considered to outweigh its benefit in treating fungal infections. There are many other antifungal medicines available that do not have this risk.

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If you are given a prescription for this medicine your pharmacist will refer you back to your doctor. If you are already taking this medicine you should make a non-urgent appointment with your doctor to discuss alternative treatment.

How does it work?

Nizoral tablets contain the active ingredient ketoconazole, which is a type of medicine called an antifungal. It is used to treat infections with fungi and yeasts.

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Ketoconazole kills fungi and yeasts by interfering with their cell membranes. It works by stopping the fungi from producing a substance called ergosterol, which is an essential component of fungal cell membranes. The disruption in production of ergosterol disrupts the fungal cell membrane, causing holes to appear in it.

The cell membranes of fungi are vital for their survival. They keep unwanted substances from entering the cells and stop the contents of the cells from leaking out. As ketoconazole causes holes to appear in the cell membranes, essential constituents of the fungal cells can leak out. This kills the fungi and treats the infection.

When taken by mouth ketoconazole may very rarely cause serious side effects on the liver. As a result, Nizoral tablets are reserved for treating fungal infections that can't be treated with other antifungals.

Warning!

Nizoral tablets should be taken with a meal.

When ketoconazole is taken by mouth it may very rarely have serious side effects on the liver. For this reason, your doctor will want to check your liver function before your treatment is started and monitor your liver function regularly during the treatment. This will involve a blood test before starting the tablets, and further blood tests after two weeks, four weeks and then every month until your treatment is finished. You should tell your doctor immediately if you experience any symptoms of a liver problem during treatment. Symptoms that may suggest a liver problem include persistent nausea and vomiting, unexplained itching, abdominal pain, loss of appetite, fatigue, dark urine or the development of jaundice (a yellow colouring to the skin and the whites of the eyes).

Make sure you take this medicine regularly and complete the course as directed by your doctor. It is important to complete the course, even if your symptoms have cleared up, otherwise there is a risk of the infection returning.

On rare occasions some people may experience symptoms such as flushing, rash, swelling of the ankles, nausea or headache if they drink alcohol while taking this medicine.

Use with caution in

People with abnormal results in liver function tests.

People who have previously experienced side effects on the liver caused by treatment with any medicine.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not been established. The manufacturer states that it is not recommended for use during pregnancy unless the potential benefits outweigh any potential risks to the developing baby. Seek medical advice from your doctor.

This medicine passes into breast milk. Mothers who need treatment with this medicine should not breastfeed while taking it. Seek medical advice from your doctor.

Label warnings

Take this medication with or after food.

Do not take indigestion remedies at the same time of day as this medication.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

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Nausea and vomiting.

Itching (pruritus).

Abdominal pain.

Diarrhoea.

Headache.

Dizziness.

Sleepiness.

Rash.

Menstrual disorders - very rare.

Erectile dysfunction - very rare.

Abnormal enlargement of breasts in men (gynaecomastia) - very rare.

Decreased numbers of blood cells called platelets in the blood (thrombocytopenia) - very rare.

Hair loss (alopecia) - very rare.

Raised pressure inside the skull - very rare.

Severe swelling of lips, face or tongue (angioedema) - very rare.

Serious liver damage that may be fatal - very rare.

Underactivity of the adrenal glands - very rare.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Nizoral tablets must not be taken in combination with any of the following medicines. This is because when ketoconazole is taken by mouth it can raise the blood levels of these medicines, resulting in an increased risk of serious side effects:

astemizole

bepridil

cilostazol

cisapride

darifenacin

disopyramide

eletriptan

eplerenone

ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine and methysergide

halofantrine

irinotecan

ivabradine

lovastatin

midazolam taken by mouth

mizolastine

nisoldipine

pimozide

quinidine

sertindole

simvastatin

sirolimus

terfenadine

triazolam

vardenafil.

Ketoconazole may also increase the blood levels of various other medicines and could increase the risk of their side effects. Other medicines affected in this way include the following:

ritonavir (ritonavir may also increase the blood level of ketoconazole)

saquinavir

sildenafil

solifenacin

sunitinib

tacrolimus

tadalafil

theophylline

tolterodine.

Ketoconazole may enhance the anti-blood-clotting effect of anticoagulant medicines such as warfarin. If you are taking this medicine in combination with an anticoagulant your blood clotting time (INR) should be monitored more frequently.

When there is a low level of acidity in the stomach, the absorption of ketoconazole is decreased. This could make it less effective at treating infection. For this reason, you should not take antacid medicines (eg for indigestion or heartburn) for at least two hours after taking Nizoral tablets. If you are taking regular medicines that decrease the acidity in the stomach (for example H2-antagonists such as ranitidine or cimetidine, or proton pump inhibitors such as lansoprazole or omeprazole), the manufacturer recommends that you take your Nizoral tablets with a cola drink.

The following medicines may reduce the amount of ketoconazole in the blood and could make it less effective at treating infection:

carbamazepine

isoniazid

nevirapine

phenytoin

rifabutin

rifampicin (ketoconazole may also reduce the blood level of rifampicin).

If you are taking the contraceptive pill there may be a very low risk that ketoconazole tablets may make it less effective at preventing pregnancy. The personal and ethical consequences of an unwanted pregnancy can be very serious and for this reason, it is recommended that women taking the pill should use an extra method of contraception (eg condoms) while taking a course of this medicine and for seven days after finishing the course. If the seven days run beyond the end of a pill packet, a new packet should be started without a break (in the case of ED pills the inactive tablets should be omitted). Ask your doctor or pharmacist for more advice.

The materials in this web site are in no way intended to replace the professional medical care, advice, diagnosis or treatment of a doctor. The web site does not have answers to all problems. Answers to specific problems may not apply to everyone. If you notice medical symptoms or feel ill, you should consult your doctor - for further information see our Terms and conditions.

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